U.S. patent number 9,125,632 [Application Number 12/253,792] was granted by the patent office on 2015-09-08 for systems and methods for cardiac remodeling.
This patent grant is currently assigned to Guided Delivery Systems, Inc.. The grantee listed for this patent is Mariel Fabro, Didier Loulmet, Eugene Serina, Niel F. Starksen. Invention is credited to Mariel Fabro, Didier Loulmet, Eugene Serina, Niel F. Starksen.
United States Patent |
9,125,632 |
Loulmet , et al. |
September 8, 2015 |
Systems and methods for cardiac remodeling
Abstract
Described herein are devices and methods for improving the
hemodynamic function of a patient. In particular, a first device
adapted to reshape an atrio-ventricular valve is used in
combination with a second device configured to further alter the
blood flow through the valve. The first device is typically an
implant positioned in the subvalvular space of a ventricle. The
second device may be an annuloplasty implant, a non-annulus valve
apparatus implant, a ventriculoplasty implant, or a cardiac rhythm
management device.
Inventors: |
Loulmet; Didier (New York,
NY), Starksen; Niel F. (Los Altos Hills, CA), Fabro;
Mariel (San Jose, CA), Serina; Eugene (Union City,
CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Loulmet; Didier
Starksen; Niel F.
Fabro; Mariel
Serina; Eugene |
New York
Los Altos Hills
San Jose
Union City |
NY
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
Guided Delivery Systems, Inc.
(Santa Clara, CA)
|
Family
ID: |
40260586 |
Appl.
No.: |
12/253,792 |
Filed: |
October 17, 2008 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20090234318 A1 |
Sep 17, 2009 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60981423 |
Oct 19, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/0401 (20130101); A61B 17/064 (20130101); A61F
2/2487 (20130101); A61B 17/00234 (20130101); A61B
2017/00783 (20130101); A61F 2/2445 (20130101); A61B
2017/0496 (20130101); A61B 17/0644 (20130101); A61B
2017/0414 (20130101); A61F 2/2481 (20130101); A61B
2017/00243 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61B 17/00 (20060101); A61B
17/04 (20060101); A61B 17/064 (20060101) |
Field of
Search: |
;623/2.36 |
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Primary Examiner: Sweet; Thomas J
Assistant Examiner: Schall; Matthew
Attorney, Agent or Firm: Morrison & Foerster LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims priority under 35 U.S.C. 119(e) to
U.S. Provisional Application No. 60/981,423 filed on Oct. 19, 2007,
which is hereby incorporated by reference in its entirety.
Claims
What is claimed is:
1. A method for reshaping a heart, comprising: positioning a first
therapy implant adjacent a first cardiac tissue using a first
delivery tool, wherein the first cardiac tissue is non-leaflet
tissue at a subvalvular space of a ventricle and the first therapy
implant comprises a first plurality of tissue anchors slidably
coupled to a first tether; reconfiguring the first cardiac tissue
using the first therapy implant; reconfiguring a second cardiac
tissue at a different non-annulus location from the first cardiac
tissue using a second therapy implant separate from the first
therapy implant that is delivered by a second delivery tool; and
withdrawing the first and second delivery tools and leaving the
first and second therapy implants within the heart.
2. The method of claim 1, wherein reconfiguring the first cardiac
tissue occurs before reconfiguring the second cardiac tissue.
3. The method of claim 1, wherein the second cardiac tissue is
inferior to a third order chordae tendineae.
4. The method of claim 1, wherein the second cardiac tissue is
superior to a papillary muscle.
5. The method of claim 1, wherein the second cardiac tissue is
inferior to a papillary muscle.
6. The method of claim 1, wherein the second therapy implant is
oriented generally perpendicular to a longitudinal axis of the
ventricle.
7. The method of claim 1, further comprising passing a guide
catheter in a retrograde direction through an aorta.
8. The method of claim 7, wherein positioning the first therapy
implant adjacent the first cardiac tissue comprises passing a first
delivery catheter through the guide catheter and toward the first
cardiac tissue.
9. The method of claim 8, further comprising withdrawing the first
delivery catheter from the guide catheter after reconfiguring the
first cardiac tissue using the first therapy implant.
10. The method of claim 7, wherein reconfiguring the second cardiac
tissue comprises passing a second delivery catheter through the
guide catheter and toward the second cardiac tissue.
11. The method of claim 1, wherein reconfiguring the first cardiac
tissue using the first therapy device comprises manipulating a
cinching member of the first therapy implant.
12. The method of claim 11, wherein the first therapy implant is
wholly contained in one heart chamber.
13. The method of claim 1, wherein the second therapy implant
comprises a means for reducing a ventricular dimension.
14. The method of claim 13, wherein the ventricular dimension is a
septolateral dimension.
15. The method of claim 1, further comprising implanting a third
therapy implant at a location different from the locations of the
first and second therapy implants.
16. The method of claim 1, wherein the first and second delivery
tools are the same tool.
Description
BACKGROUND OF THE INVENTION
Blood returning to the heart from the peripheral circulation and
the lungs generally flows into the atrial chambers of the heart and
then to the ventricular chambers, which pump the blood back out of
the heart. During ventricular contraction, the atrio-ventricular
valves between the atria and ventricles, i.e. the tricuspid and
mitral valves, close to prevent backflow or regurgitation of blood
from the ventricles back to the atria. The closure of these valves,
along with the aortic and pulmonary valves, maintains the
unidirectional flow of blood through the cardiovascular system.
Disease of the valvular apparatus can result in valve dysfunction,
where some fraction of the ventricular blood regurgitates back into
the atrial chambers.
There are several possible structural causes for atrio-ventricular
valve dysfunction, including: loss of pliability of the annulus
leading to decreased contractibility; widening of the annulus;
thickening, shortening or swelling of the leaflets; dilation of the
ventricle; elongation or breaking of the chordae tendineae; and
elongation of the attachment of the chordae tendineae with the
papillary muscles or ventricular wall. Structural abnormalities at
one or more of these anatomical sites may eventually lead to loss
of coaptation of the leaflets, loss of competence of the valve and
decreased efficiency of the heart as a one-way pumping mechanism.
When the latter occurs, various signs and symptoms may be seen in
patients, including breathlessness or lack of stamina and heart
murmurs.
Traditional treatment of heart valve stenosis or regurgitation,
such as mitral or tricuspid regurgitation, involves an open-heart
surgical procedure to replace or repair the valve. Currently
accepted treatments of the mitral and tricuspid valves include:
valvuloplasty, in which the affected leaflets are remodeled to
perform normally; repair of the chordae tendineae and/or papillary
muscle attachments; and surgical insertion of an "annuloplasty"
ring. This requires suturing a flexible support ring over the
annulus to constrict the radial dimension. Other surgical
techniques to treat heart valve dysfunction involve fastening (or
stapling) the valve leaflets to each other or to other regions of
the valve annulus to improve valve function (see, e.g., U.S. Pat.
No. 6,575,971).
BRIEF SUMMARY OF THE INVENTION
Described herein are devices and methods for improving the
hemodynamic function of a patient. In particular, a first device
adapted to reshape an atrio-ventricular valve is used with a second
device configured to further alter the blood flow through the
valve. The first device may be an implant positioned in the
subvalvular space of a ventricle. The second device may be an
annuloplasty implant, a non-annulus valve apparatus implant, a
ventriculoplasty implant, or a cardiac rhythm management
device.
In one embodiment, a method for reshaping a heart is provided. The
method comprises accessing a first cardiac tissue at a subvalvular
space of a ventricle, positioning a first therapy device adjacent
the first cardiac tissue using a first delivery tool, reconfiguring
the first cardiac tissue using the first therapy device and
reconfiguring a second cardiac tissue at a different location from
the first cardiac tissue using a second therapy device. Thus, more
than one therapy device may be used. In some embodiments, a
septolateral dimension of a heart chamber is reduced.
In one embodiment, a method for treating an atrio-ventricular valve
is provided. The method comprises accessing a first cardiac tissue
at a subvalvular space of an atrio-ventricular valve, wherein the
first cardiac tissue is non-leaflet cardiac tissue. Sometimes, the
subannular groove region of the left ventricle may be specifically
accessed. A first therapy device may be positioned adjacent to the
first cardiac tissue using a first delivery tool and the first
therapy device may be used to reconfigure the first cardiac tissue.
A second therapy device adapted to alter flow through the valve may
be also implanted. Occasionally, a third therapy device adapted to
alter flow through the valve is also implanted. In some
embodiments, the first therapy device comprises a first plurality
of tissue anchors slidably coupled to a first tether. Reconfiguring
the first cardiac tissue may occur before implanting the second
therapy device.
In some further embodiments, implanting the second therapy device
may comprise accessing a second cardiac tissue inferior to a third
order chordae tendineae, positioning the second therapy device
adjacent the second cardiac tissue and reconfiguring the second
cardiac tissue using the second therapy device. The second cardiac
tissue may be inferior or superior to a papillary muscle, and
sometimes may be oriented generally perpendicular to a longitudinal
axis of a ventricle, or generally parallel to the base of the
ventricle. The second therapy device may be selected from a group
consisting of: an annuloplasty device, a myocardial tensioning
device, a myocardial compression device, a valve leaflet clip, a
chordae tendineae clip device, a left ventricular assist device, a
cardiac rhythm management device, and the like.
Sometimes, the method of treatment comprises passing a guide
catheter in a retrograde direction through an aorta, passing a
first delivery catheter through the guide catheter and toward the
first cardiac tissue, withdrawing the first delivery catheter from
the guide catheter after reconfiguring the first cardiac tissue
using the first device, passing a second delivery catheter through
the guide catheter and toward the second cardiac tissue, and
manipulating a cinching member of the first therapy device. In some
further embodiments, manipulating the cinching member of the first
therapy device is performed in the left ventricle. Also, in some
particular embodiments, the second therapy device comprises a means
for reducing a left ventricle dimension.
In another embodiment, a method for reducing valve regurgitation is
provided. The method comprises accessing a ventricle in a patient
with a pre-existing annuloplasty implant, positioning a therapy
device adjacent a wall of the ventricle, and reconfiguring the wall
of the ventricle using the therapy device. The therapy device may
comprise a plurality of tissue anchors movably coupled to a tether.
At least one tissue anchor may be self-attaching or self-securing.
The method may be performed to reduce a distance between a first
papillary muscle and a second papillary muscle in the ventricle, or
reduce a distance between a valve leaflet and a papillary muscle.
The papillary muscle may be attached to the valve leaflet by a
chordae tendineae, or may be an unassociated papillary muscle.
In still another embodiment, a kit for altering atrio-ventricular
valve flow is provided. The kit comprises a guide catheter, a first
delivery catheter configured for insertion into the guide catheter,
a first plurality of tissue anchors slidably coupled to a first
tether and configured for loading into the first delivery catheter,
a second delivery catheter configured for insertion into the guide
catheter, and a second plurality of tissue anchors slidably coupled
to a second tether and configured for loading into the second
delivery catheter. In some embodiments, one or both of the delivery
catheters is pre-loaded with a plurality of tissue anchors.
BRIEF DESCRIPTION OF THE DRAWINGS
The structure and method of using the invention will be better
understood with the following detailed description of embodiments
of the invention, along with the accompanying illustrations, in
which:
FIG. 1A is a cross-sectional view of a heart with a guide catheter
device advanced through the aorta into the left ventricle;
FIG. 1B is a flowchart representation of a method for delivering at
least two anchors into a region of a heart valve annulus;
FIGS. 1C to 1K provide a detailed depiction of a method for
advancing at least two delivery catheters to the subannular groove
region of a heart valve to deliver at least two anchors into a
region of annular tissue;
FIGS. 2A and 2B are cross-sectional views of a portion of a heart,
schematically illustrating the positioning of a flexible device for
treatment of a mitral valve annulus;
FIGS. 2C and 2D are cross-sectional views of a portion of a heart,
showing the positioning and deployment of a flexible anchor
delivery device for treatment of a mitral valve annulus;
FIG. 3 is a perspective view of a distal portion of an anchor
delivery device;
FIG. 4 is a perspective view of a segment of a distal portion of an
anchor delivery device, with the anchors in an undeployed shape and
position;
FIG. 5 is a different perspective view of the segment of the device
shown in FIG. 4;
FIG. 6 is a perspective view of a segment of a distal portion of an
anchor delivery device, with anchors in a deployed shape and
position;
FIGS. 7A through 7E are cross-sectional views of an anchor delivery
device, illustrating a method for delivering anchors to valve
annular tissue;
FIGS. 8A and 8B are top-views of a plurality of anchors coupled to
a self-deforming coupling member, with the coupling member shown in
an undeployed shape and a deployed shape, respectively;
FIGS. 9A through 9C are various perspective views of a distal
portion of a flexible anchor delivery device;
FIGS. 10A through 10F demonstrate a method for applying anchors to
a valve annulus and cinching the anchors to tighten the annulus,
using an anchor delivery device;
FIGS. 11A through 11C are schematic cross-sectional views of one
embodiment of the invention comprising a self-forming anchor
attaching to tissue;
FIGS. 12A and 12B illustrate transseptal and transapical approaches
to the left ventricle, respectively;
FIG. 13 is a schematic cut-away view of another embodiment of the
invention comprising a mitral valve reshaping implant and a
ventricular remodeling implant;
FIGS. 14A through 14D depict various embodiments of support members
for stabilizing an anchor delivery device against a myocardial
surface;
FIG. 15 is a schematic representation of a heart with a mitral
valve reshaping implant, a ventricular reshaping implant, and leads
from a cardiac rhythm management system;
FIG. 16 is a schematic representation of a heart with a coronary
sinus reshaping implant and a ventricular reshaping implant;
FIG. 17 is a schematic representation of a heart with a mitral
valve leaflet clip and a ventricular reshaping implant;
FIG. 18 is a lateral schematic view of a left ventricle with a
mitral valve reshaping implant and a ventricular tension
implant;
FIG. 19A is a schematic representation of a left ventricle with a
dyskinetic wall segment; FIG. 19B is a schematic representation of
the left ventricle of FIG. 19A following myocardial splinting with
a ventricular remodeling implant;
FIG. 20 is a schematic view of an external surface of the heart
with an external cardiac support device;
FIGS. 21A and 21B are schematic views of an external surface of the
heart with a mitral valve reshaping implant placed on the
epicardial surface;
FIGS. 22A through 22C are schematic representations of an
implantation of another embodiment of a ventricular reshaping
implant;
FIGS. 23A and 23B illustrate another embodiment of a ventricular
reshaping implant; FIGS. 23C and 23D depict embodiments of delivery
catheters;
FIG. 24A is a perspective view of a delivery catheter, FIG. 24B is
a front view of the delivery catheter of FIG. 24A, and FIGS. 24C
and 24D are side and bottom views, respectively, of a portion of
the delivery catheter of FIG. 24A;
FIG. 25 is a schematic view of the heart illustrating various
dimensions of a heart chamber; and
FIG. 26 is a schematic view of the heart illustrating various
dimensions of a heart chamber.
DETAILED DESCRIPTION OF THE INVENTION
While existing treatment options, such as the implantation of an
annuloplasty ring or edge-to-edge leaflet repair, have been
developed to treat structural abnormalities of the disease process,
these treatments may fail to return the patient to a normal
hemodynamic profile. Furthermore, atrio-ventricular valve
regurgitation itself can also cause secondary changes to the
cardiac function. For example, compensatory volume overload of the
left ventricle may occur over time to maintain the net forward flow
from the ventricle. This in turn will cause ventricular dilation,
and further worsen mitral valve regurgitation by reducing valve
coaptation. Ventricular dilation may also cause non-structural
changes to the heart that can cause arrhythmias or
electrophysiological conduction delays.
Devices, systems and methods are generally described herein for
reshaping or remodeling atrio-ventricular valves. In some
variations, procedural efficiencies may be gained by facilitating
the delivery of two or more treatment devices to one or more
treatment sites using some common delivery components. The
implantation procedures may be transvascular, minimally invasive or
other "less invasive" surgical procedures, but the procedures can
also be performed with open or limited access as well.
When used for treatment of a cardiac valve dysfunction, the methods
may generally involve contacting an anchor delivery device,
delivering a plurality of slidably coupled anchors from the anchor
delivery device, and drawing the anchors together to tighten the
annulus or annular tissue. Devices include an elongate catheter
with a housing at or near the distal end for releasably housing a
plurality of coupled anchors, as well as delivery devices for
facilitating advancement and/or positioning of an anchor delivery
device. Self-securing anchors having any of a number of different
configurations may be used in some embodiments. Additional devices
include delivery devices for facilitating delivery and/or placement
of an anchor delivery device at a treatment site.
Valve Reshaping
Referring now FIG. 1A, a cross-sectional depiction of a heart H is
shown with an anchor delivery device guide catheter 100 advanced in
a retrograde direction through the aorta A and into the left
ventricle LV. Retrograde, as used herein, generally refers to a
direction opposite the expected flow of blood. In one embodiment,
this access route is used to reach the subvalvular space 106. Guide
catheter 100 is generally a flexible elongate catheter which may
have one or more curves or bends toward its distal end to
facilitate placement of the distal end 102 of the catheter 100 at
the desired location. The distal end 102 of guide catheter 100 may
be configured to be positioned at an opening into the subvalvular
space 106 or within the subvalvular space 106, such that subsequent
delivery devices may be passed through guide catheter 100 into the
subvalvular space 106. Although the retrograde aortic access route
preferably starts from a percutaneous or peripheral access site, in
some embodiments of the invention, aortic access may be achieved by
an incision in the ascending aorta, descending aorta, aortic arch
or iliac arteries, following surgical, thorascopic or laparoscopic
access to a body cavity.
Access to the other chambers of the heart may be performed through
percutaneous or venous cut-down access, including but not limited
to transjugular, subclavian and femoral vein access routes. When
venous access is established, access to the right atrium RA, the
right ventricle RV, the tricuspid valve TV and other right-sided
cardiac structures can occur. Furthermore, access to left-sided
heart structures, such as the left atrium LA, left ventricle LV,
mitral valve and the aortic valve, may be subsequently achieved by
performing a transseptal puncture procedure, which is discussed in
greater detail below.
Access to the heart H may also be transthoracic, with a delivery
device being introduced into the heart via an incision or port in
the heart wall. Open heart surgical procedures may also be used to
provide access for the methods and devices described herein. In
some embodiments, hybrid access involving a combination of access
methods described herein may be used. In one specific example, dual
access to a valve may be achieved with a combination of venous and
arterial access sites. User manipulation of both ends of a
guidewire placed across a valve may improve positioning and control
of the catheter and the implants. In other examples of hybrid
access, both minimally invasive and surgical access is used to
implant one or more cardiac devices.
Other embodiments of the invention also include treatment of the
tricuspid valve annulus, tissue adjacent the tricuspid valve
leaflets TVL, or any other cardiac or vascular valve. Thus,
although the description herein discloses specific examples of
devices and methods of the invention for mitral valve repair, the
devices and methods may be used in any suitable procedure, both
cardiac and non-cardiac. For example, in other embodiments, the
mitral valve reshaping devices and procedures may be used with the
tricuspid valves also, and certain embodiments may also be adapted
for use with the pulmonary and aortic valves. Likewise, the other
examples provided below are directed to the left ventricle, but the
devices and methods may also be adapted by one of ordinary skill in
the art for use in the right ventricle or either atrium. The
devices and methods may also be used with the great vessels of the
cardiovascular system, for example, to treat aortic root
dilatation.
FIG. 1B is a flowchart of a method 120 for deploying at least two
anchors in the region of a heart valve annulus. As shown there,
this illustrative method comprises advancing a guide catheter to
the subannular groove region 122, advancing a guidewire through a
lumen of the guide catheter 124, advancing a tunnel catheter over
the guidewire 126, and proximally withdrawing the guidewire from
the tunnel catheter 128. After the guidewire has been proximally
withdrawn, a first delivery catheter may be advanced through the
lumen of the tunnel catheter 130 and a first anchor may be deployed
into a first region of the heart valve annular tissue 132. The
first anchor may then be fixedly attached or otherwise secured to a
guide element, such as a tether. In this way, after the anchor is
deployed, the guide element may remain attached to the anchor and
the guide element may be used as a track or monorail for the
advancement of additional delivery catheters thereover.
The guide element may be made from any suitable or desirable
biocompatible material. The guide element may be braided or not
braided, woven or not woven, reinforced or impregnated with
additional materials, or may be made of a single material or a
combination of materials. For example, the guide element may be
made from a suture material (e.g., absorbable suture materials such
as polyglycolic acid and polydioxanone, natural fibers such as
silk, and artificial fibers such as polypropylene, polyester,
polyester impregnated with polytetrafluoroethylene, nylon, etc.),
may be made from a metal (absorbable or non-absorbable), may be
made from a metal alloy (e.g., stainless steel), may be made from a
shape memory material, such as a shape memory alloy (e.g., a nickel
titanium alloy), may be made from combinations thereof, or may be
made from any other biocompatible material. In some variations,
when pulled proximally, the guide element will cinch or reduce the
circumference of the atrio-ventricular valve annulus or the annular
tissue. In certain variations, the guide element may be in the form
of a wire. The guide element may include multiple layers, and/or
may include one or more coatings. For example, the guide element
may be in the form of a polymer-coated wire. In certain variations,
the guide element may be formed of a combination of one or more
sutures and one or more wires. As an example, the guide element may
be formed of a suture that is braided with a wire. In some
variations, the guide element may be formed of one or more
electrode materials. In certain variations, the guide element may
be formed of one or more materials that provide for the telemetry
of information (e.g., regarding the condition of the target
site).
In some variations, the guide element may include one or more
therapeutic agents (e.g., drugs, such as time-release drugs). As an
example, the guide element may be partially or entirely coated with
one or more therapeutic agents. In certain variations, the guide
element may be used to deliver one or more growth factors and/or
genetic regenerative factors. In some variations, the guide element
may be coated with a material (e.g., a polymer) that encapsulates
one or more therapeutic agents, or in which one or more therapeutic
agents are embedded. The therapeutic agents may be used, for
example, to treat the target site to which the guide element is
fixedly attached or otherwise secured. In certain variations, the
guide element may include one or more lumens through which a
therapeutic agent can be delivered.
After the first anchor has been deployed in the region of the heart
valve annular tissue, the first delivery catheter may be withdrawn
proximally and the tunnel catheter may then be positioned at a
different location about the subannular groove region 134. A second
delivery catheter may then be advanced over the guide element
through the lumen of the tunnel catheter 136. During advancement of
the second delivery catheter over the guide element, the guide
element may enter the second delivery catheter through an opening
at its distal end, and exit the second delivery catheter through an
opening in its side wall that is proximal to its distal end.
Alternatively, the guide element may enter the second delivery
catheter through an opening at its distal end, and exit the second
delivery catheter through an opening at its proximal end. After the
second delivery catheter has been advanced over the guide element
through the lumen of the tunnel catheter, a second anchor is
deployed into a second region of the heart valve annular tissue
138.
As illustrated in FIG. 2A, a distal portion 102 of the delivery
device 100 is positioned in a desired location under a valve
leaflet L and adjacent a ventricular wall VW. The valve annulus VA
generally comprises an area of heart wall tissue at the junction of
the ventricular wall VW and the atrial wall AW that is relatively
fibrous and, thus, significantly stronger than leaflet tissue and
other heart wall tissue. It is noted, however, that considerable
structural variations of the annulus exist within patient
populations and that attempted delivery of an implant to the valve
annulus VA may instead contact or attach to the tissue adjacent to
the valve annulus. The term "annular tissue" as used herein shall
include the valve annulus and the tissue adjacent or surrounding
the valve annulus.
The distal portion 102 of the delivery device 100 may be advanced
into position generally under the valve annulus VA by any suitable
technique, some of which are described below. The distal portion
102 of the delivery device 100 may be used to deliver anchors to
the valve annular tissue, to stabilize and/or expose the annulus,
or both. In one embodiment, using a delivery device 100 having a
flexible elongate body as shown in FIG. 1, a flexible distal
portion 102 may be positioned in the left ventricle LV at the level
of the mitral valve leaflets MVL using any of a variety of access
routes described herein. The distal portion 102 may be advanced to
a region 104 under the posterior valve leaflet. Referring to FIG.
2A, in some variations the region 104 may be generally bordered by
the inner surface of the ventricular wall VW, the inferior surface
of valve leaflets L, and the third order chordae tendineae CT
connected directly to the ventricular wall VW and the leaflet L. It
has been found that when a flexible anchor delivery device 100 is
passed, for example, under the mitral valve via an intravascular
approach, the delivery device 100 may be inserted into the space
104 and advanced along the subannular groove region 104 either
partially or completely around the circumference of the valve.
Other examples of deployment locations are described elsewhere
herein. Once in the region 104, the distal portion 102 of the
delivery device 100 may be positioned proximate to the intersection
of the valve leaflet(s) and the ventricular wall VW, which is near
to the valve annulus VA. These are but examples of possible access
routes of an anchor delivery device to a valve annulus, and any
other access routes may be used.
In some embodiments, the guide catheter 100 may comprise a curvable
portion with a radius in an expanded/curved state that is greater
than a radius of the valve annulus or the subannular groove region.
The relative size of this portion of the guide catheter 100, when
positioned within the smaller sized ventricle, may exert a radially
outward force that can improve the surface contact between guide
catheter 100 and the left ventricle LV. For example, in one
embodiment guide catheter 100 in the expanded state has a radius
about 25%-50% larger that the valve annulus or ventricle
chamber.
In some variations, the distal portion 102 of the delivery device
100 may include a shape-changing portion which enables distal
portion 102 to conform to the shape of the valve annulus VA, the
region 104, or other portion of the heart chamber. The delivery
device 100 may be introduced through the vasculature with the
shape-changing distal portion in a generally straight, flexible
configuration. Once the delivery device 100 is generally positioned
beneath the leaflet in proximity to the intersection between the
leaflet and the interior ventricular wall, the shape of the distal
portion 102 may be changed to conform to the annulus and the shape
may be "locked" to provide sufficient stiffness or rigidity to
permit the application of force from the distal portion 102 to the
annulus or annular tissue.
In some embodiments, a shape-changing portion may be sectioned,
notched, slotted or segmented and one of more tensioning members
such as tensioning cords, wires or other tensioning devices coupled
with the shape-changing portion may be used to shape and rigidify
distal portion 102. A segmented distal portion, for example, may
include multiple segments coupled with two tensioning members, each
providing a different direction of articulation to the distal
portion. A first bend may be created by tensioning a first member
to give the distal portion a C-shape or similar shape to conform to
the annular tissue, while a second bend may be created by
tensioning a second member to articulate the C-shaped member
upwards against the annular tissue. In another embodiment, a shaped
expandable member, such as a balloon, may be coupled with the
distal portion 102 to provide for shape changing/deforming.
For example, in transthoracic delivery methods and other
embodiments, the distal portion 102 may be shaped, and the method
may involve introducing distal portion 102 under the valve
leaflets. The shaped distal portion 102 may be rigid or formed from
any suitable material such as spring stainless steel, a
super-elastic or shape memory material such as nickel-titanium
alloy (e.g., Nitinol), or the like. In embodiments configured for
open surgical access, the delivery devices may be made with stiffer
materials when the maneuverability through a transvascular route is
not required, but in other embodiments, flexible, catheter-like
delivery devices may still be used with open surgical
procedures.
In addition to delivering anchors to the annular tissue, the
delivery device 100 (and specifically distal portion 102) may be
used to stabilize and/or expose the valve annulus or annular
tissue. Such stabilization and exposure are described fully in U.S.
patent application Ser. No. 10/656,797, which is hereby
incorporated by reference in its entirety. For example, once the
distal portion 102 is positioned generally under the annular
tissue, force may be applied to the distal portion 102 to stabilize
the valve annulus VA or annular tissue, as shown in FIG. 2B. Such
force may be directed in any suitable direction to expose, position
and/or stabilize the annulus or annular tissue. In another example,
an upward and lateral force is shown in FIG. 2B by the solid-headed
arrow drawn from the center of the distal portion 102. In other
examples, only upward, only lateral, or any other suitable force(s)
may be applied. With application of force to the distal portion
102, the annular tissue may rise or project outwardly, thus
exposing the annular tissue for easier viewing or access. The
applied force may also stabilize the valve annulus VA or valve
annular tissue, also facilitating surgical procedures and
visualization.
Some embodiments of the invention may include a stabilization
component as well as an anchor delivery component. For example,
some embodiments may include two flexible members, one for
contacting the atrial side of a valve annulus and the other for
contacting the ventricular side. In some embodiments, such flexible
members may be used to "clamp" the annulus between them. One of
such members may be an anchor delivery member and the other may be
a stabilization member, for example. Any combination and
configuration of stabilization and/or anchor delivery members is
contemplated.
Referring now to FIGS. 2C and 2D, an anchor delivery device 108 is
schematically shown delivering an anchor 110 to a valve annulus VA.
Anchor 110 is shown first housed within delivery device 108 in FIG.
2C and then delivered to the annulus VA, as depicted in FIG. 2D. Of
course, although the delivery and position of the anchor 110 is
described with respect to the valve annulus VA, one or more anchors
110 may be secured to the valve annulus VA or other structures
accessible from the region 104. As is shown, in some embodiments,
anchors 110 may have a relatively straight configuration when
housed in delivery device 108, with two sharpened tips and a loop
in between the tips. Upon deployment from delivery device 108, the
tips of anchor 110 may curve in opposite directions to form two
semi-circles, circles, ovals, overlapping helices or the like.
Additional anchor embodiments are described below, and may also be
found in U.S. patent application Ser. No. 11/202,474, which is
hereby incorporated by reference in its entirety. Multiple coupled
anchors 110 may be delivered, and the anchors 110 may be drawn
together to tighten the valve annulus.
Although delivery device 108 is shown having a circular
cross-sectional shape in FIGS. 2C and 2D, it may alternatively have
any other suitable shape. In one embodiment, for example, it may be
advantageous to provide a delivery device having an ovoid or
elliptical cross-sectional shape. Such a shape may help ensure that
the device is aligned, when positioned between a corner formed by a
ventricular wall and a valve leaflet, such that one or more
openings in the delivery device is oriented to deliver the anchors
into valve annulus tissue. To further enhance contacting of the
annular tissue and/or orientation of the delivery device, some
embodiments may further include an expandable member, coupled with
the delivery device, which expands to urge or press or wedge the
delivery device into the corner formed by the ventricle wall and
the leaflet to contact the valve annulus. Such enhancements are
described further below.
FIGS. 1C to 1K provide a more detailed depiction of the method
shown in flowchart form in FIG. 1B. In FIGS. 1C to 1K, the mitral
valve MV of FIG. 1A is depicted schematically from an inferior
perspective looking up, but in other embodiments the tricuspid
valve may be accessed. Referring to FIG. 1C, a guide catheter 140
is advanced to subannular groove region 142 using any of the access
routes (or any other suitable access routes) previously described.
After guide catheter 140 has been positioned at the desired
location in subannular groove region 142, a guidewire 142 is
advanced through the lumen of guide catheter 140. The guidewire 144
may then be advanced beyond the distal end 146 of guide catheter
140, so that guidewire 144 extends further along subannular groove
region 142 than guide catheter 140, as shown in FIG. 1D.
After the guidewire 144 has been positioned in the subannular
groove region 142, a tunnel catheter 148 may be advanced through
guide catheter 140, over guidewire 144, which is shown in FIG. 1E.
Tunnel catheter 148 may be any suitable catheter, and in some
instances, it is desirable that the tunnel catheter be pre-shaped
or pre-formed at its distal end, such as the tunnel catheter
illustrated in FIG. 1E. The tunnel catheter may have a pre-shaped
distal portion comprising a curve. In this way, the tunnel catheter
may more easily conform to the geometry of the atrio-ventricular
valve. It should also be understood that any of the catheters or
guidewires described here may be pre-shaped or pre-formed to
include any number of suitable curves. Of course, the guidewires
and/or catheters described here may also be steerable.
After tunnel catheter 148 has been positioned in the subannular
groove region 142, guidewire 144 may be withdrawn proximally as
shown in FIG. 1F. After guidewire 144 has been withdrawn, a
delivery catheter 150 may then be advanced through the lumen of the
tunnel catheter 148. As shown in FIG. 1G, a distal portion 152 of
delivery catheter 150 is advanced toward an opening 154 in distal
portion 156 of tunnel catheter 148. In some embodiments, the
delivery catheter 150 may be extended through the opening 154 of
the tunnel catheter 148. As shown in FIG. 1H, an anchor 158, which
is attached to a guide element (shown in FIG. 11 as a tether 158),
may then be deployed from delivery catheter 150. The anchor 158 may
be deployed from the delivery catheter 150 in any suitable fashion,
including but not limited to a push-pull wire, using a plunger, or
other suitable actuation technique. Similarly, anchor 158 may be
attached to tether 158 by any suitable attachment method. For
example, one or more knots, welded regions, and/or adhesives may be
used. Alternate embodiments for anchor deployment and anchor
attachments are described in U.S. patent application Ser. Nos.
11/583,627, and 61/083,109, which are hereby incorporated by
reference in its entirety.
The anchors for use with the methods and devices described here may
be any suitable anchor. The anchors may be made of any suitable
material, may be any suitable size, and may be of any suitable
shape. The anchors may be made of one material or more than one
material. Examples of anchor materials include super-elastic or
shape memory materials, such as nickel-titanium alloys and spring
stainless steel. Examples of anchor shapes include T-tags, rivets,
staples, hooks (e.g., C-shaped or semicircular hooks, curved hooks
of other shapes, straight hooks, barbed hooks), multiple looped
anchors, and clips. The anchors may be configured to self-expand
and self-secure into tissue, but need not be configured in such a
fashion. Additionally, while the delivery and deployment of
multiple anchors of the same shape over a single guide element have
been described, in some variations, a single guide element can be
used to deliver and deploy multiple anchors having different
shapes. Similarly, in certain variations, a single guide element
can be used in the delivery and deployment of multiple anchors
having different sizes. Illustrative examples of suitable anchors
are described in more detail, for example, in U.S. patent
application Ser. No. 11/202,474, which is hereby incorporated by
reference in its entirety.
The anchor 158, shown in FIG. 1H, may be configured to self-expand
as it exits delivery catheter 150 and to self-secure into a region
of the mitral valve annulus, but may also be used to in other
regions of the heart. It should be understood that the one or more
anchors may be deployed into the annulus directly, while other
anchors may be secured to other tissue in the vicinity of the
subannular groove region. For example, one or more anchors may be
secured to the tissue below the annulus. After anchor 158 has been
deployed, delivery catheter 150 may be proximally withdrawn. FIG.
11 shows anchor 158, attached to tether 160 and secured to the
mitral valve annulus AN. As shown in FIG. 1J, tunnel catheter 148
may then be moved to a different location or position in the
subannular groove region or the heart, and a second delivery
catheter 162 is advanced through the lumen of tunnel catheter 148,
over tether 160, as shown in FIG. 1K.
Before delivery catheter 162 is advanced through tunnel catheter
148, the tether 160 may be threaded into delivery catheter 162, and
slidably engaged with a second anchor 164. Any of a number of
different methods can be used to thread a guide element, such as a
tether, into a delivery catheter, and to engage the guide element
with an anchor. Other methods are disclosed in U.S. patent
application Ser. No. 11/202,474, which was previously incorporated
by reference, and threading devices are described, for example, in
U.S. patent application Ser. No. 11/232,190, which is hereby
incorporated by reference in its entirety. With reference now to
FIG. 1K, after delivery catheter 162 has been advanced through
tunnel catheter 148, and is used to deploy anchor 164 before being
withdrawn from the tunnel catheter 148.
Tunnel catheter 148 may be formed of any of a number of different
materials. Examples of suitable materials include polymers, such as
polyether-block co-polyamide polymers, copolyester elastomers,
thermoset polymers, polyolefins (e.g., polypropylene or
polyethylene, including high-density polyethylene and low-density
polyethylene), polytetrafluoroethylene, ethylene vinyl acetate,
polyamides, polyimides, polyurethanes, polyvinyl chloride (PVC,
fluoropolymers (e.g., fluorinated ethylene propylene,
perfluoroalkoxy (PFA) polymer, polyvinylidenefluoride, etc.),
polyetheretherketones (PEEKs), and silicones. Examples of
polyamides that may be included in tunnel catheter (410) include
Nylon 6 (e.g., Zytel.RTM. HTN high performance polyamides from
DuPont.TM.), Nylon 11 (e.g., Rilsan.RTM. B polyamides from Arkema
Inc.), and Nylon 12 (e.g., Grilamid.RTM. polyamides from
EMS-Grivory, Rilsan.RTM. A polyamides from Arkema Inc., and
Vestamid.RTM. polyamides from Degussa Corp.). In some variations,
tunnel catheter 148 may be formed of multiple polymers. For
example, tunnel catheter 148 may be formed of a blend of different
polymers, such as a blend of high-density polyethylene and
low-density polyethylene. While the wall of tunnel catheter 148 is
formed of a single layer, some variations of tunnel catheters may
include walls having multiple layers (e.g., two layers, three
layers). Furthermore, some variations of tunnel catheters may
include at least two sections that are formed of different
materials and/or that include different numbers of layers.
Additionally, certain variations of tunnel catheters may include
multiple (e.g., two, three) lumens. The lumens may, for example, be
lined and/or reinforced (e.g., with braiding).
FIGS. 24A to 24D show various detailed views of one embodiment of a
delivery catheter 1200 that can be used to deliver one or more
anchors to a target site. As shown in FIG. 24A, the delivery
catheter 1200 has a distal region 1204 including a tip 1202, an
anchor-holding region 1206 including a primary lumen 1208, an
intermediate region 1210, a secondary lumen 1212, and a proximal
region 1214 including primary lumen 1208. An anchor 1216 is
disposed within primary lumen 1208, in the anchor-holding region
1206. While only one anchor is shown in the anchor-holding region,
some variations of delivery catheters may include an anchor-holding
region that is adapted to hold multiple anchors. Similarly, while
the variation shown in FIGS. 24A to 24D depict anchors adapted to
be deployed from the distal end of the delivery catheter, it should
be understood that the anchors may be deployed from any suitable
region of the delivery catheter, as desirable. For example, if
desirable, the anchor may be delivered out of a side port or hole
on the delivery catheter.
As shown in FIGS. 24A to 24D, a tether 1218 is threaded into a slot
1219 of tip 1202 (shown in FIGS. 24C and 24D), and through an
eyelet 1226 of anchor 1216. After extending through the eyelet, the
tether may exit the primary lumen 1208, and extend along an
exterior surface 1221 of delivery catheter 1200 for the remainder
of the length of the anchor-holding region, as shown in FIG. 24C.
The tether then enters secondary lumen 1212, and extends through
the length of the secondary lumen, exiting the secondary lumen at
an end of distal region 1214. An actuator 1220 may be slidably
disposed within primary lumen 1208, and can be used to deploy
anchor 1216. The actuator is in the form of a pushable generally
tubular member, although other forms of actuators may be used. For
example, in some variations, a solid rod may be used as an
actuator. Other embodiments of the delivery catheter are described
in U.S. patent application Ser. No. 11/202,474, which was
previously incorporated by reference.
It should also be understood that while some embodiments of the
invention utilize multiple anchors being delivered via multiple
delivery catheters, other methods of delivering the anchors may be
used. For example, in some instances, it may be desirable to
deliver multiple anchors from a single delivery catheter, as
described in more detail below and in U.S. patent application Ser.
No. 11/201,949, which is hereby incorporated by reference in its
entirety. Similarly, it may be desirable to combine multiple anchor
delivery and deployment via a single delivery catheter with single
anchor delivery and deployment via a single delivery catheter.
With reference now to FIG. 3, one embodiment comprises an anchor
delivery device 200, which suitably includes an elongate shaft 204
having a distal portion 202 configured to deliver a plurality of
anchors 210, coupled with a tether 212, and configured for
attachment to annular tissue. The tethered anchors 210 are housed
within a housing 206 of the distal portion 202, along with one or
more anchor retaining mandrels 214 and an expandable member 208.
Many variations may be made to include one or more of these
features, and various parts may be added or eliminated. Some of
these variations are described further below, but no specific
variation(s) should be construed as limiting.
Housing 206 may be flexible or rigid in some variations. In some
embodiments, for example, flexible housing 206 may comprise
multiple segments configured such that housing 206 is deformable by
tensioning a tensioning member coupled to the segments. In some
embodiments, housing 206 is formed from an elastic material having
a geometry selected to engage and optionally shape or constrict the
annular tissue. For example, the rings may be formed from spring
stainless steel, super-elastic shape memory alloys such as
nickel-titanium alloys (e.g., Nitinol), or the like. In other
embodiments, the housing 206 could be formed from an inflatable or
other structure that can be selectively rigidified in situ, such as
a gooseneck or lockable element shaft, any of the rigidifying
structures described above, or any other rigidifying structure.
"Anchors," for the purposes of this application, are defined to
include any of a variety of fasteners. Thus, anchors 210 may
comprise C-shaped or semicircular hooks, curved hooks of other
shapes, straight hooks, barbed hooks, clips of any kind, T-tags, or
any other suitable fastener(s). In one embodiment, as described
above, anchors may comprise two tips that curve in opposite
directions upon deployment, forming two intersecting semi-circles,
circles, ovals, helices or the like. In some embodiments, anchors
210 are self-deforming. By "self-deforming" it is meant that
anchors 210 are biased to change from a first undeployed shape to a
second deployed shape upon release of anchors 210 from restraint in
housing 206. Such self-deforming anchors 210 may change shape as
they are released from housing 206 and enter annular tissue, and
secure themselves to the tissue. Self-deforming anchors 210 may be
made of any suitable material such as spring stainless steel, or a
super-elastic or shape-memory material like nickel-titanium alloy
(e.g., Nitinol).
In other embodiments, the anchors 210 may be made of a
non-shape-memory material and may be loaded into housing 206 in
such a way that they change shape upon release. For example,
anchors 210 that are not self-deforming may be secured to tissue
via crimping, firing or other application of mechanical force to
facilitate tissue penetration and/or securement. Even self-securing
anchors may be crimped in some embodiments of the invention, to
provide enhanced attachment to tissue. In some embodiments, anchors
210 may comprise one or more bioactive agents. In another
embodiment, anchors 210 may comprise electrode components. Such
electrodes, for example, may sense various parameters including but
not limited to impedance, temperature and electrical signals. In
other embodiments, such electrodes may be used to supply energy to
tissue at ablation or sub-ablation amounts. In still other
embodiments, the anchors may be incorporated with an implantable
pacing lead or an implanted sensor of a congestive heart failure
monitor. Examples of a congestive heart failure monitor include the
HeartPOD.TM. Implantable Heart Failure Therapy System by Savacor,
Inc. (Los Angeles, Calif.) and the OptiVol.RTM. feature of the
InSync Sentry.TM. cardiac resynchronization therapy-defibrillator
by Medtronic, Inc. (Minneapolis, Minn.). These systems are
described in greater detail in U.S. Pat. Nos. 6,970,742 and
6,931,272, of which those portions relating to suitable devices and
methods are herein incorporated by reference. Delivery of the
anchors may be accomplished by any suitable device and technique,
such as by simply releasing the anchors by hydraulic balloon
delivery as discussed further below. Any number, size and shape of
the anchors 210 may be included in housing 206.
In another embodiment, the anchors 210 may generally C-shaped or
semicircular in their undeployed form, with the ends of the "C"
being sufficiently sharpened to penetrate tissue. Between the ends
of the C-shaped anchor 210, an eyelet may be formed for allowing
slidable passage of the tether 212. To maintain the anchors 210 in
their C-shaped, undeployed state, anchors 210 may be retained
within housing 206 by two mandrels 214, one mandrel 214 retaining
each of the two arms of the C-shape of each anchor 210. Mandrels
214 may be retractable within elongate catheter body 204 to release
anchors 210 and allow them to change from their undeployed C-shape
to a deployed shape. The deployed shape, for example, may
approximate a partial or complete circle, or a circle with
overlapping ends, the latter appearing similar to a key ring. Such
anchors are described further below, but generally may be
advantageous in their ability to secure themselves to annular
tissue by changing from their undeployed to their deployed shape.
In some variations, anchors 210 may also be configured to lie flush
with a tissue surface after being deployed. By "flush" it is meant
that no significant amount of an anchor protrudes from the surface,
although some small portion may protrude.
The retaining mandrels 214 may have any suitable cross-sectional
shape, cross-sectional area, length and be made of any suitable
material, such as stainless steel, titanium, nickel-titanium alloys
(e.g., Nitinol), or the like. Some embodiments may not include a
mandrel, or may have one mandrel, two mandrels, or more than two
mandrels.
In some embodiments, the anchors 210 may be released from mandrels
214 to contact and secure themselves to annular tissue without any
further force applied by the delivery device 200. Some embodiments,
however, may also include one or more expandable members 208, which
may be expanded to help drive anchors 210 into tissue. Expandable
member(s) 208 may have any suitable size and configuration and may
be made of any suitable material(s). Any of a variety of mechanical
and hydraulic expandable members known in the art may be included
in housing 206.
Referring now to FIGS. 4 and 5, a segment of a distal portion 302
of an anchor delivery device suitably includes a housing 306,
multiple tensioning members 320 for applying tension to housing 306
to change its shape, two anchor retaining mandrels 314 slidably
disposed in housing 306, multiple anchors 310 slidably coupled with
a tether 312, and an expandable member 308 disposed between anchors
310 and housing 306. As can be seen in FIGS. 4 and 5, housing 306
may include multiple segments to allow the overall shape of housing
306 to be changed by applying tension to tensioning members 320. As
also is evident from the drawings, "C-shaped" anchors 310 may
actually have an almost straight configuration when retained by
mandrels 314 in housing 306. Thus, for the purposes of this
application, "C-shaped" or "semicircular" refers to a very broad
range of shapes including a portion of a circle, a slightly curved
line, a slightly curved line with an eyelet at one point along the
line, and the like.
With reference now to FIG. 6, the same segment of distal portion
302 is shown, but mandrels 314 have been withdrawn from two mandrel
apertures 322, to release anchors 310 from housing 306.
Additionally, expandable member 308 has been expanded to drive
anchors out of housing 306. Anchors 310, having been released from
mandrels 314, have begun to change from their undeployed, retained
shape to their deployed, released shape.
Referring now to FIGS. 7A to 7E, a cross-section of a distal
portion 402 of an anchor delivery device is shown in various stages
of delivering an anchor to annular tissue. In FIG. 7A, distal
portion 402 is positioned against the annular tissue, an anchor 410
is retained by two mandrels 414, a tether 412 is slidably disposed
through an eyelet on anchor 410, and an expandable member 408 is
coupled with housing 406 in a position to drive anchor 410 out of
housing 406. When retained by mandrels 414, anchor 410 may be in
its undeployed shape. As discussed above, mandrels 414 may be
slidably retracted, as designated by the solid-tipped arrows in
FIG. 7A, to release anchor 410. In some embodiments, anchors 410
may be released one at a time, such as by retracting mandrels 414
slowly, may be released in groups, or may all be released
simultaneously, such as by rapid retraction of mandrels 414.
In the example depicted in FIG. 7B, anchor 410 has begun to change
from its undeployed shape to its deployed shape (as demonstrated by
the hollow-tipped arrows) and has also begun to penetrate the
annular tissue. Empty mandrel apertures 422 demonstrate that
mandrels 414 have been retracted at least far enough to release
anchor 410. In FIG. 7B, expandable member 408 has been expanded to
drive anchor 410 partially out of housing 406 and further into the
annular tissue VA. Anchor 410 also continues to move from its
undeployed towards its deployed shape, as shown by the
hollow-tipped arrows. In FIG. 7D, anchor 410 has reached its
deployed shape, which is roughly a completed circle with
overlapping ends or a "key ring" shape. In FIG. 7E, delivery device
402 has been removed, leaving a tethered anchor in place in the
valve annulus. Of course, there will typically be a plurality of
tethered anchors secured to the annular tissue. Tether 412 may then
be cinched to apply force to anchors 410 and cinch and tighten the
valve annulus.
With reference now to FIGS. 8A and 8B, a diagrammatic
representation of another embodiment comprising coupled anchors is
shown. Here, anchors 510 are coupled to a self-deforming or
deformable coupling member or backbone 505. In some examples, this
backbone 505 may be another embodiment of a tether. The backbone
505 may be fabricated, for example, from nickel-titanium alloys
(e.g., Nitinol), spring stainless steel, or the like, and may have
any suitable size or configuration. In one embodiment, as in FIG.
8A, backbone 505 is shaped as a generally straight line when held
in an undeployed state, such as when restrained within a housing of
an anchor deliver device. When released from the delivery device,
backbone 505 may change to a deployed shape having multiple bends,
as shown in FIG. 8B. By bending, backbone 505 shortens the
longitudinal distance between anchors, as demonstrated by the
solid-tipped arrows in FIG. 8B. This shortening process may act to
reshape the annular tissue into which anchors 510 have been
secured. Thus, anchors 510 coupled to backbone 505 may be used to
reshape annular tissue without using a separate tether or applying
tethering force. In other embodiments, an elastic tether may be
used as the backbone 505. In still other embodiments, backbone may
also be coupled with a termination member to further cinch the
annular tissue. In such an embodiment, the backbone 505 is adapted
to be at least partially conformable or cinchable, such that when
force is applied to anchors 510 and backbone 505 via a tether,
backbone 505 bends further to allow further cinching of the annular
tissue.
In another embodiment, shown in FIGS. 9A to 9C, a flexible distal
portion of an anchor delivery device 520 includes a housing 522
coupled with an expandable member 524. Housing 522 may be
configured to house multiple coupled anchors 526 and an anchor
contacting member 530 coupled with a pull cord 532. Housing 522 may
also include multiple apertures 528 for allowing egress of anchors
526. For clarity, delivery device 520 is shown without a tether in
FIGS. 9A and 9C, but FIG. 9B shows that a tether 534 may extend
through an eyelet, loop or other portion of each anchor 526, and
may exit each aperture 528 to allow for release of the plurality of
anchors 526. The various features of this variation are described
further below.
In the specific embodiment in FIGS. 9A to 9C, anchors 526 are
relatively straight and lie relatively in parallel with the long
axis of delivery device 522. Anchor contacting member 530, which
may comprise a device such as a ball, plate, hook, knot, plunger,
piston, or the like, may generally have an outer diameter that is
nearly equal to or slightly less than the inner diameter of housing
522. Contacting member 530 is disposed within the housing, distal
to a distal-most anchor 526, and may be retracted relative to
housing 522 by pulling pull cord 532. When retracted, anchor
contacting member 530 contacts and applies force to a distal-most
anchor 526 to cause release of that anchor 526 from housing 522 via
one of the apertures 528. Contacting member 530 is then pulled
farther proximally to contact and apply force to the next anchor
526 to deploy that anchor 526, and so on.
Retracting contacting member 530 to push anchors 526 out of
apertures 528 may help cause anchors 526 to secure themselves to
the tissue adjacent the apertures 528. Using anchors 526 that are
relatively straighter/flatter in configuration when undeployed may
allow anchors 526 with relatively large deployed sizes to be
disposed in (and delivered from) a relatively small housing 522. In
one embodiment, for example, anchors 526 that deploy into a shape
approximating two intersecting semi-circles, circles, ovals,
helices, or the like, and that have a radius of one of the
semi-circles of about 3 mm may be disposed within a housing 522
having a diameter of about 5 French (1.67 mm) and more preferably
about 4 French (1.35 mm) or even smaller. Such anchors 526 may
measure about 6 mm or more in their widest dimension. In some
embodiments, housing 522 may have a diametrical dimension ("d") and
anchor 526 may have a diametrical dimension ("D") in the deployed
state, and the ratio of D to d may be at least about 3.5. In other
embodiments, the ratio of D to d may be at least about 4.4, and
more preferably at least about 7, and even more preferably at least
about 8.8. These are only examples, however, and other larger or
smaller anchors 526 may be disposed within a larger or smaller
housing 522. The dimensions of an anchor may vary depending on the
particular usage. For example, anchors used for ventriculoplasty
may permit the use of larger anchors than those used for
annuloplasty due to fewer space constraints in the main compartment
of the ventricles than in the subvalvular spaces. Furthermore, any
convenient number of anchors 526 may be disposed within housing
522. In one variation, for example, housing 522 may hold about 1 to
about 20 anchors 526, and more preferably about 3 to about 10
anchors 526. Other variations may hold more anchors 526.
Anchor contacting member 530 and pull cord 532 may have any
suitable configuration and may be manufactured from any material or
combination of materials. In alternative embodiments of the
invention, contacting member 530 may be pushed by a pusher member
to contact and deploy anchors 526. Alternatively, any of the anchor
deployment devices and methods previously described may be
used.
Tether 534, as shown in FIG. 9B, may comprise any of the tethers or
tether-like devices described above, or any other suitable device.
Furthermore, in some variations, multiple tethers may be provided.
In such variation and each tether may or may not be coupled to
every anchor, and some or all of the anchors may be coupled to more
than one tether. Tether 534 may be generally attached to a
distal-most anchor 526 at an attachment point 536. The attachment
itself may be achieved via a knot, weld, adhesive, or by any other
suitable attachment mechanism. Tether 234 then extends through an
eyelet, loop or other similar configuration on each of the anchors
526 so as to be slidably coupled with the anchors 526. In the
particular embodiment shown, tether 534 exits each aperture 528,
then enters the next-most-proximal aperture, passes slidably
through a loop on an anchor 526, and exits the same aperture 528.
By entering and exiting each aperture 528, tether 534 allows the
plurality of anchors 526 to be deployed into tissue and cinched.
Alternate embodiments of housing 522, anchors 526 and tether 534
may also be used. For example, housing 522 may include a
longitudinal slit through which tether 534 may pass, thus allowing
tether 534 to reside wholly within housing before deployment.
Expandable member 524 is an optional feature of anchor delivery
device 520, and thus may be included in some embodiments and not in
others. In some embodiments, expandable member 524 will be coupled
with a surface of housing 522, will have a larger radius than
housing 522, and will be configured such that when it is expanded
as housing 522 nears or contacts the valve annulus, expandable
member 524 will push or press housing 522 into enhanced contact
with the annulus. For example, expandable member 524 may be
configured to expand within a space near the corner formed by a
left ventricular wall and a mitral valve leaflet.
With reference now to FIGS. 10A to 10F, one embodiment of the
invention comprises a method for applying a plurality of tethered
anchors 526 to the annular tissue of a heart. As shown in FIG. 10A,
an anchor delivery device 520 is first contacted with the valve
annulus VA or annular tissue such that openings 528 are oriented to
deploy anchors 526 into the tissue. Such orientation may be
achieved by any suitable technique. In one embodiment, for example,
a housing 522 having an elliptical cross-sectional shape may be
used to orient openings 528. Contact between housing 522 and the
annular tissue may be enhanced by expanding expandable member 524
to wedge housing 522 within the deepest portion of the subannular
groove region.
Generally, delivery device 520 may be advanced into any suitable
location for treating any valve by any suitable advancing or device
placement method. Many catheter-based, minimally invasive devices
and methods for performing intravascular procedures, for example,
are well known, and any such devices and methods, as well as any
other devices or method later developed, may be used to advance or
position delivery device 520 in a desired location. For example, in
one embodiment a steerable guide catheter is first advanced in a
retrograde fashion through an aorta, typically via access from a
femoral artery. The steerable catheter is passed into the left
ventricle of the heart and thus into the space formed by the mitral
valve leaflets, the left ventricular wall and chordae tendineae of
the left ventricle. Once in this space, the steerable catheter is
advanced along a portion (or all) of the circumference of the
mitral valve. A sheath is advanced over the steerable catheter
within the space below the valve leaflets, and the steerable
catheter is removed through the sheath. Anchor delivery device 520
may then be advanced through the sheath to a desired position
within the space, and the sheath may be removed. In some cases, an
expandable member coupled to delivery device 520 may be expanded to
wedge or otherwise move delivery device 520 into the corner formed
by the left ventricular wall and the valve leaflets to enhance its
contact with the valve annulus. This is but one exemplary method
for advancing delivery device 520 to a position for treating a
valve, and other suitable methods, combinations of devices, etc.
may be used.
As shown in FIG. 10B, when delivery device 520 is positioned in a
desired location for deploying anchors 526, anchor contacting
member 530 is retracted to contact and apply force to a most-distal
anchor 526 to begin deploying anchor 526 through aperture 528 and
into the valve annulus VA (or annular tissue). FIG. 10C shows
anchor 526 further deployed out of aperture 528 and into valve
annulus VA. FIG. 10D shows the valve annulus VA transparently so
that further deployment of anchors 526 can be seen. As shown, in
one embodiment, anchors 526 include two sharpened tips that move in
opposite directions upon release from housing 522 and upon
contacting the valve annulus VA. Between the two sharpened tips, an
anchor 526 may be looped or have any other suitable eyelet or other
device for allowing slidable coupling with a tether 534.
Referring now to FIG. 10E, anchors 526 are seen in their fully
deployed or nearly fully deployed shape, with each pointed tip (or
"arm") of each anchor 526 having curved to form a circle or
semi-circle. In some variations anchors 526 may have any other
suitable deployed and undeployed shapes, as described more fully
above. FIG. 10F shows anchors 526 deployed into the valve annulus
VA and coupled to tether 534, with the distal-most anchor 526
fixedly coupled to tether 524 at attachment point 536. At this
stage, tether 534 may be cinched to tighten the annular tissue,
thus reducing valve regurgitation. In some embodiments, valve
function may be monitored by means such as echocardiogram and/or
fluoroscopy, and tether 534 may be cinched, loosened, and adjusted
to achieve a desired amount of tightening as evident via the
employed visualization technique(s). When a desired amount of
tightening is achieved, the implant may be fixed using any of a
variety of termination devices and methods.
For example, in one embodiment, cinching tether 534, attaching
tether 534 to most-proximal anchor 526, and cutting tether 534 are
achieved using a termination device (not shown). The termination
device may comprise, for example, a catheter advanceable over
tether 534 that includes a cutting member and a nickel-titanium
alloy (e.g., Nitinol) knot or other attachment member for attaching
tether 534 to most-proximal anchor. The termination catheter may be
advanced over tether 534 to a location at or near the proximal end
of the tethered anchors 526. It may then be used to apply opposing
force to the most-proximal anchor 526 while tether 534 is cinched.
Attachment and cutting members may then be used to attach tether
534 to most-proximal anchor 526 and cut tether 534 just proximal to
most-proximal anchor 526. Such a termination device is only one
possible way of accomplishing the cinching, attachment and cutting
steps, and any other suitable device(s) or technique(s) may be
used. Additional devices and methods for terminating (e.g.,
cinching and fastening) may be found, for example, in U.S. patent
application Ser. Nos. 11/232,190 and 11/270,034, both of which are
hereby incorporated by reference in their entirety. In some
embodiments, the termination device is located in the same heart
chamber as the remaining portions of the implant, which permits the
implant to be wholly implanted in a single heart chamber. In other
embodiments, however, a portion of the implant passes transmurally
through a septal wall or an outer wall of a heart chamber. In these
embodiments, the termination member and optionally one or more
anchors may be located in a different heart chamber.
In some embodiments, it may be advantageous to deploy a first
number of anchors 526 along a first portion of annular tissue,
cinch the first anchors to tighten that portion of the annular
tissue, move the delivery device 520 to another portion of the
annular tissue, and deploy and cinch a second number of anchors 526
along a second portion of the annular tissue. Such a method may be
more convenient, in some cases, than extending delivery device 520
around all or most of the circumference of the annular tissue, and
may allow a shorter, more maneuverable housing 522 to be used.
In other embodiments, similar to that shown in FIGS. 10A to 10F,
the anchors 526 may be driven out of delivery device 520 through a
biocompatible material attached to delivery device 520, thereby
attaching the biocompatible material to the annular tissue. Several
devices and methods for attaching biocompatible material using
anchors are described in U.S. patent application Ser. No.
11/201,949, which is herein incorporated by reference in its
entirety. For example, in one embodiment, a Dacron strip may be
attached to delivery device 520, extending along device 520 and
covering apertures 528. Anchors 526 are then driven out of delivery
device 520, through the Dacron strip, into the annular tissue, thus
detaching the Dacron strip from device 520 and attaching it to the
annular tissue. Such a biocompatible material may facilitate tissue
ingrowth of anchors 526 and may enhance attachment generally to the
annular tissue. In an alternative embodiment, multiple pieces of
biocompatible material, such as separate pieces of material
disposed over each of apertures 528, may be used. For example, in
one embodiment multiple discs of Dacron material are disposed over
multiple apertures 528.
In another embodiment, a distal portion of delivery device 520 may
be detachable from a proximal portion of delivery device 520. Such
a variation may be configured such that when anchors 526 are
deployed from device 520, the distal portion of device 520 detaches
from the proximal portion and is attached, via anchors 526, to the
annular tissue. In one variation, for example, anchors 526 may
pierce through the distal portion of device 520, rather than
exiting device 520 through apertures 528. The distal portion may be
detachable via any suitable means, such as perforations or the
like.
In several embodiments of the invention, self-forming anchors 900
are stored in the delivery device in a straightened configuration,
coupled with a tether 902, as shown in FIG. 11A. Anchors 900 are
held or restrained in that straightened state, while their deployed
configuration is non-linear or curved. Thus, when the straightened
anchor 900 is released from the delivery device into tissue T, the
anchor 900 actually pulls itself into the tissue T, as shown in
FIG. 11B, due to the storage of potential energy in the
straightened state and the tendency of each of the arms 901 of
anchors 900 to drive the tip of the arm into the tissue as
illustrated. Arms 901 are joined together at a junction 903. Each
arm 901 is braced against the other arm so that forces exerted by
tissue T on each arm 901 are opposed by the other arm 901 wherein
the arms are joined to one another. This eliminates the need for an
anchor driving device, such as required with staples, thus
substantially simplifying the assembly and method. In addition,
bracing arms 901 against one another also helps to reduce or
eliminate problems associated with tissue deflection. As shown by
the hollow-tipped arrows in FIG. 11B, the anchor 900 pulls itself
into tissue T as it assumes its natural, curved shape, and exerts
forces in vertical, horizontal and curved directions. Finally,
after pulling itself into tissue and assuming its natural shape, as
in FIG. 11C, anchor 900 is substantially embedded in the tissue T.
Various anchor designs and deployment methods are disclosed, for
example, in U.S. patent application Ser. Nos. 10/741,130,
10/792,681, 10/900,980, 11/255,400, and 10/901,555, which are
hereby incorporated by reference in their entirety.
As explained previously, although one access route to the region
104 or space 106 is a retrograde route through the aorta A to the
heart H, other access routes may also be used. Referring to FIG.
12A, with a heart H is shown in cross section, an elongate anchor
delivery device 150 may be introduced within the heart H by a
transseptal puncture procedure. Transseptal punctures may be
performed using a Mullins introducer sheath with a Brockenbrough
curved needle through the interatrial septum to access the left
atrium LA, but any of a variety of other transseptal puncture
devices may be used. From the left atrium LA, supravalvular access
to the mitral valve may be achieved, as well as antegrade access to
the left ventricle LV through the mitral valve. Similarly, access
from the right ventricle RV to the left ventricle LV may be
obtained by transseptal puncture of the ventricular septum. In
still other embodiments, a catheter device may access the coronary
sinus and a valve procedure may be performed directly from the
sinus.
Surgical approaches that may be used have been described above but
also include but are not limited to transcatheter procedures made
through surgical incisions in the aorta or myocardium. In one
particular embodiment, depicted in FIG. 12B, a transapical approach
with a surgical delivery device 114 is utilized. In some instances,
a transapical approach may provide a more linear route to the
subvalvular space 106. The transapical approach may also reduce
potential effects of a myocardial incision on cardiac output, as
the apical wall 112 may contribute less mechanical effect on left
ventricular ejection fraction compared to other sections of the
myocardial wall.
Synergistic Implants
In one embodiment, illustrated in FIG. 13, reshaping of the annular
tissue of the mitral valve with a cinching implant 706 may be
combined with the reconfiguration of the subvalvular apparatus
using one or more additional cinching implants 710. The reshaping
of the annular tissue may be performed with the embodiments
described above, or with other implants. However, unlike some
implants, the valve reshaping implants described herein may also be
adaptable for implantation in a more inferior position in
ventricle. A plurality of tethered anchors may be secured to the
myocardium adjacent the papillary muscle and then cinched to
tension the myocardium and cause repositioning of one or more
papillary muscles. In some embodiments, one or more of the anchors
may be attached to or looped around the papillary muscle
itself.
In one embodiment, depicted schematically in FIG. 13, the anchors
may be oriented circumferentially with respect to the long axis of
the ventricle LV between the base 702 and the apex 704 of the
ventricle LV. When cinched, the implant 710 reduces the relative
distance between the papillary muscles 708. In some instances the
papillary muscle 708 may be displaced in the presence of dilated
cardiomyopathy, or as a result of ventricular remodeling secondary
to mitral valve regurgitation. By reducing the distance between the
papillary muscles 708, the valve leaflet coaptation may be improved
by alleviating the pull of the mitral valve leaflets MVL by the
taut chordae tendineae (not shown) attached to displaced papillary
muscles 708. One or more imaging modalities, including but not
limited to magnetic resonance imaging, spiral CT, fluoroscopy or
ultrasound, may be used to visualize the valvular apparatus and to
determine the preferred orientation of the cinching implant to
achieve the desired effect. For example, if ultrasound imaging
identifies redundant chordae tendineae as one source of valve
regurgitation, one or more cinching implants may placed with a
longitudinal orientation between the associated papillary muscle
708 and the apex 704 of the ventricle LV to increase tension in the
chordae and reduce leaflet prolapse.
Even where a valve reshaping implant adequately treats the valve
regurgitation, the placement of cinching implant in an inferior
location in the ventricle may still be beneficial for treating or
limiting ventricular dilation. Under the LaPlace principle, by
reducing the radius of the heart chamber, myocardial strain from
volume overload can be reduced and may lead to some recovery of
myocardial function over time. Therefore, in addition to
repositioning of the papillary muscles 708 to improve valvular
function, the ventricular implant 710 may also improve the
contractile function of the left ventricle LV. Various imaging
modalities mentioned previously can be used to identify locations
to reduce ventricular dimensions, and in some embodiments, multiple
cinching implants may be used in the ventricle to achieve the
desired result.
The reshaping of a ventricle may be performed or assessed along any
of a variety of dimensions or vectors. For example, referring to
FIG. 25, in some embodiments of the invention, the reshaping of a
ventricle or a valve may occur with respect to the diameter B or
the circumference C about a valve orifice. In one embodiment, the
diameter B and the circumference C with respect to the region 104
of a ventricle is reshaped. In addition to the reshaping of to
valvular structures, reshaping can also be performed with respect
to the non-valvular structures of a heart chamber. For example, one
or more of the diameters or circumferences of the ventricle may be
reshaped. As shown in FIG. 25, the diameter B' and the
circumference C' of the ventricle located generally at or above the
papillary muscles may be reshaped. The diameter B'' and
circumference C'' of the ventricle at or below the papillary
muscles may also be reshaped. The orientation of the diameter and
circumference that is reshaped or assessed can vary, but in some
embodiments, the diameter or circumference may be in a generally
perpendicular orientation with respect to a longitudinal axis of a
ventricle. One of skill in the art will understand that the
longitudinal axis may be characterized in a number of ways,
including but not limited to a longitudinal axis from a valve
orifice to an apex of a heart chamber, or from the apex of a heart
chamber to a point that generally splits the ventricular volume in
half. Similarly, some of the implantation dimensions or vectors may
also be oriented with respect to the anterior-posterior axis or the
septolateral axis of the heart chamber.
Referring to FIG. 26, in some embodiments, the distances A, D
between a papillary muscle and a valve leaflet may be reshaped.
This distance A or D may be between a papillary muscle and its
associated valve leaflet, or between a papillary muscle and an
unassociated valve leaflet, respectively. Although the distances A,
D depicted in FIG. 26 are shown from the tip of the papillary
muscle, these distances may also be measured from the base of the
papillary muscle. Similarly, distances involving a valve leaflet
may be measured from the distalmost section, the middle or the base
of the valve leaflet. In other embodiments, the reshaping of the
heart may occur between the apex of a heart chamber and one or more
valves. For example, reshaping may occur along the distance E
between the outlet valve and the apex of a heart chamber, and/or
along the distance F between the inlet valve and the apex.
Thus, one or more shortening implants, including the cinching
implants described herein, may be generally placed or oriented
between or along one or more of the dimensions or vectors, as
exemplified above. In some embodiments, multiple implants may be
placed in a generally parallel arrangement or in a fan-like pattern
along one or more of the dimensions or vectors. The placement of a
shortening implant is not limited to the vectors or locations
described herein, and may occur with any angle, length or skewing
as needed. Although the dimensions depicted in FIGS. 25 and 26 are
wholly contained within a single heart chamber, in other
embodiments, the dimensions may include cardiac sites outside of a
single heart chamber.
Referring back to FIG. 13, although the two cinching implants
depicted have similar size anchors and tether lengths, in other
embodiments these features may be optimized for the intended
implant location. For example, larger anchors may be used when
performing ventriculoplasty. Likewise, the length of the tether and
the number of coupled anchors may be increased with myocardial wall
applications due to the larger circumferential dimensions of the
ventricle compared to the annular tissue regions. Furthermore, the
desired tissue-related characteristics of the cinching implants may
differ, depending on the implant location. For example, tissue
fibrosis around a valve reshaping implant may be desirable to
improve implant biocompatibility and to resist further annulus
dilation. Further details regarding tissue fibrosis around a valve
reshaping implant may be found in U.S. patent application Ser. No.
11/255,400, which was previously incorporated by reference. Tissue
fibrosis around a ventricular implant, however, may reduce the
contractility and compliance of the myocardial wall and result in
reduced ejection fractions. For this reason, it may be desirable to
configure valve and ventricular implants for different tissue
responses. For example, ventricular implants may benefit from an
anti-proliferative drug coating to limit tissue fibrosis. The
anti-proliferative drug may be any of a variety of
anti-proliferative agents known in the art, including but not
limited to paclitaxel, sirolimus, everolimus, a corticosteroid and
the like.
Although a number of surgically implanted ventricular devices and
procedures are known in the art, the percutaneous or transvascular
implantation of a ventricular device may pose a significant
challenge, due to the instability from the wall motion of a beating
heart. To assure adequate contact between the delivery device and
the myocardium and reliable positioning of a ventricular cinching
implant, the delivery device may be stabilized against a less
mobile portion of the cardiac structure during the implantation
procedure. In some embodiments, the delivery device for a
ventricular implant may be stabilized in the subannular groove, the
subvalvular space, or the apex of the left ventricle.
FIG. 14A depicts an embodiment of the ventricular implant delivery
device, comprising a support member configured to seat in the
apical region of the left ventricle during implantation. The
support member depicted in FIG. 14A is a helical support member 652
coupled to a distal end of anchor delivery device 658, but other
shapes and configurations may also be used. In other embodiments,
helical support member 652 may alternately extend out of a guide
catheter 650 to contact the heart wall 651 and support the anchor
delivery device 658. Preferably the support member 652 has a
delivery configuration with a reduced profile to facilitate passage
of the support member 652 to the target site, and an expanded
configuration with an enlarged profile for seating against the
apical region 704 of the left ventricle or other stable region of
an anatomical structure. Helical member 652 may be made of any
suitable material, including but not limited to nickel-titanium
alloys (e.g., Nitinol), stainless steel or the like. Any suitable
mechanism may be used for extending helical member 652 into the
left ventricle or other chamber. For example, helical member 652
may be pushed out of guide catheter 650, but may alternatively be
extended out the guide catheter with extension of anchor delivery
device 658.
In another embodiment illustrated in FIG. 14B, the delivery device
may be stabilized against the superior surfaces of the papillary
muscles 708. In some examples, stabilization against the papillary
muscles 708 may provide mid-chamber support during implantation of
a ventricular cinching implant 710. The anchor delivery device 668
may optionally comprise a deployable J- or U-shaped support member
662 that is movably coupled with a distal portion of an anchor
delivery device 668, both of which are advanceable through a guide
catheter 660. Upon being advanced out of the distal end of guide
catheter 660, U-shaped member 662 may automatically spring out, or
alternatively may be manually extended, to contact the inner
surface of the heart wall and/or to contact a papillary muscle 708.
Manual extension of the U-shaped member 662 may permit the user to
titrate the positioning of the delivery device to the desired
location in the heart chamber. Such a U-shaped member 662 may
automatically deform from a straight configuration for delivery
through guide catheter 660 into a U-shaped configuration, such as
if member 662 is made of spring stainless steel or nickel-titanium
alloys (e.g., Nitinol). In another embodiment, the U-shaped member
662 may be connected to anchor delivery device 668 at or near the
distal end of the device 668 and may be pushed distally to force
the U-shaped member 662 to expand into its U-shape. In still
another embodiment, the U-shaped member 662 may be attached
proximally and may be pulled into its expanded configuration. Any
suitable method for changing the shape of U-shaped member 662 from
straight to U-shaped may be used in some variations.
In another embodiment depicted in FIG. 14C, the U-shaped member 662
may optionally include an expandable member 667, such as an
inflatable balloon. Expandable member 667 may be expanded to
provide further force against and support of anchor delivery device
668, to enhance its contact with ventricular wall 651. In FIG. 14C,
the expandable member 667 is circumferentially mounted on the
U-shaped member 662, similar to a balloon angioplasty-type catheter
but with a greater expansion diameter. In some embodiments, the
balloon may have an expanded diameter of at least about 1 cm, at
least about 2 cm, of at least about 3 cm. In other embodiments of
the invention, the expandable member 667 may be mounted and
inflated directly from the delivery device, without a U-shaped
member 662.
In another embodiment of the invention, shown in FIG. 14D, multiple
spring members 672 may be coupled with a distal end of an anchor
delivery device 678 to provide force against an inner surface of a
heart wall (solid tipped arrows) to support the anchor delivery
device 678 against the heart wall of the heart chamber (hollow
tipped arrows). Thus, an anchor delivery device may include any of
a number of suitable support members to support an anchor delivery
device against the myocardium, thus possibly enhancing the ability
of the delivery device to delivery tissue anchors to the target
tissue in the left ventricle.
In some of the embodiments, the support members of an anchor
delivery device may have a fixed length or configuration such that
the anchor delivery device is configured to position an implant at
a single level or position relative to an anatomical structure or
site in the heart, e.g. the apex of the left ventricle. Further
manipulation by the physician may permit the anchor delivery device
to be positioned at other levels with a fixed configuration device.
In other embodiments, the length of the support member(s) may be
manipulated with respect to the guide catheter or the anchor
delivery device to permit variable positioning of the anchor
delivery device at different levels or sites of the heart chamber.
The different sites include but are not limited to the apex, the
region between the apex and the lower boundary of the papillary
muscles, the papillary muscles, the subvalvular space, and the
subannular groove region. The implantation sites can also be
characterized by a percentage or percentage range with respect to
an axis of the particular heart chamber. These percentages include
but are not limited to about 0%, about 10%, about 20%, about 30%,
about 40%, about 50%, about 60%, about 70%, about 80%, about 90%
and about 100%. Along a longitudinal axis of the left ventricle,
for example, the apex may be characterized as about 0% of the
longitudinal axis while the subannular groove region may be
characterized as about 100% of the longitudinal axis.
Although in some embodiments, the cinching implants may be oriented
at an angle in the heart chamber so that they are orthogonal to the
longitudinal axis of the heart chamber, in other embodiments the
implants may be oriented at any angle or range of angles, from
about zero degrees to about 180 degrees with respect to the
longitudinal axis, including but not limited to about 15 degrees,
30 degrees, about 45 degrees, about 60 degrees, about 75 degrees,
about 90 degrees, about 105 degrees, about 120 degrees, about 135
degrees, about 150 degrees, about 165 degrees. With non-orthogonal
angles, the implant may be located across two or more levels of the
heart chamber as described previously. A particular implantation
angle may be facilitated by the fixed or variable angle between the
support member and the anchor delivery device, or from manual
positioning by the physician.
Another challenge involving a papillary reconfiguration or
ventriculoplasty implant is the potential arrhythmogenic risk to a
patient. Patients who could benefit from such implants may be
at-risk for conduction abnormalities from ventricular dilatation.
However, annular tissue may be relatively electro-physiologically
inert compared to the myocardial tissue. Patients with tissue
anchors attached to the myocardium may benefit from an implantation
of a cardiac rhythm management device with a defibrillator
component. FIG. 15 depicts one such embodiment, comprising multiple
implants. In some examples, multiple implants may be used for
synergistic treatment of mitral regurgitation and related sequelae.
Here, the patient has a mitral valve reshaping implant 706 for
treatment of valve regurgitation, a ventriculoplasty implant 710
for treatment of ventricle dilatation, and a set of electrodes 712
for monitoring and treatment of arrhythmias and conduction delays
that may reduce ventricular contractile efficiency. In addition to
treating common risks associated with mitral regurgitation, the
pacemaker-defibrillator leads 712 and the cinching implants 706,
710 may be synergistically configured for implantation using a
common guide catheter, which may reduce implantation procedure time
and costs.
Although some of the preceding examples utilize two minimally
invasive tissue anchor implants for reshaping cardiac structures,
not all of the implants need to have a design comprising tissue
anchors. In FIG. 16, for example, a coronary sinus annuloplasty
implant 714, such as the C-CURE.TM. device by Mitralife, Inc.
(Santa Rosa, Calif.), may be used in conjunction with the tissue
anchor implant. Different tissue anchor-based implants may be used,
including those described in U.S. Pat. Pub. 2007/0112424 assigned
to Mitralign, Inc., of which those portions that relate to suitable
devices and delivery methods for use herein incorporated by
reference. Various designs of the coronary sinus annuloplasty
implants are disclosed in U.S. Pat. No. 6,402,781 to Langberg et
al., of which those portions relating to suitable devices and
methods for use herein are also incorporated by reference. The
embodiment depicted in FIG. 16 also illustrates the use of dual
valve reshaping implants to achieve a further degree of annulus
diameter reduction. The use of both peripheral and central
reshaping forces from two difference types of mitral valve implants
706, 714 may achieve better annulus reshaping than any annuloplasty
implant alone.
Also, while both types of implants 706, 714 may be placed during
the same procedure, the second implant may be placed at a later
date. With reference again to FIG. 16, a patient with an existing
mitral valve reshaping implant 714 may receive an additional
implant 706 to reduce any residual regurgitation from the original
surgery, or any regurgitation that develops later as a result of
disease progression. In other embodiments, a patient with a
pre-existing surgically implanted annuloplasty ring may receive a
second mitral valve annuloplasty implant that is translumenally
implanted by a catheter. The second implant may also be placed
several weeks, months or years after the original implant.
The use of a tissue-anchor implant may allow further annular tissue
reshaping without requiring removal of an existing coronary sinus
implant or surgically implanted annuloplasty ring. The
self-deploying design of tissue anchor design may also generate
less concern that the second implant is interfering with existing
implant because the self-deploying design permits securement of the
implant to a wider range of structures or surfaces.
FIGS. 17, 18 and 20 depict the use of an anchor-based ventricular
implant 710 along other complementary cardiac devices for the
multimodal treatment of mitral valve regurgitation and related
sequalae. In FIG. 17, a clip device 716, such as the one produced
by Evalve, Inc. (Redwood City, Calif.) may be used to restrain the
free edges of a mitral valve for reducing regurgitation, while a
cinching implant is used synergistically to reduce ventricle size
and alleviate volume overload. Leaflet clips and other suitable
valvular apparatus lasso devices are described in U.S. Pat. No.
6,629,534, those portions of which relating to suitable devices and
delivery methods for use herein are also incorporated by reference.
Conversely in FIG. 18, a myocardial tension implant 718, such as
the Coapsys.RTM. device by Myocor.RTM. Inc. (Maple Grove, Minn.),
may be used with a cinching valve reshaping implant 706. Various
designs for transmural and transchamber myocardial tension implants
718 and related implantation tools are described in U.S. Pat. Nos.
5,961,440 and 6,260,552, both of which the portions relating to
suitable devices and delivery methods are herein incorporated by
reference.
In addition to the transmural myocardial tension device shown in
FIG. 18, other implants requiring access to the epicardial surface
may also be used with annular tissue and ventricular cinching
implants 706, 710. Another example of an external cardiac support
device that limits cardiac dilatation is the CorCap.TM. cardiac
support device by Acorn Cardiovascular, Inc. (St. Paul, Minn.),
which depicted in FIG. 20 and described in U.S. Pat. No. 7,278,964,
those portions of which relating to suitable devices and delivery
methods for use herein are also incorporated by reference.
One or more cinching implants may also be applied to the epicardial
surface of the heart. Referring to FIG. 21A, an epicardial cinching
implant 722 may be placed on the heart H using a thorascopic
procedure or an open surgical procedure through an incision in the
pericardial sac. In one embodiment, the cinching implant 722 may be
secured at a circumferential epicardial location inferior to the
left circumflex artery LCX and then cinched to reduce the diameter
of the mitral valve annulus (not shown). During some procedures,
when positioning the implant 722, to the cinching implant 722 may
be positioned to limit or avoid impingement of the coronary
arterial and venous system. This can be done with direct
visualization of the epicardial surface 732 using a minimally
invasive fiber optic scope or by direct visualization with the
creation of a pericardial flap or window. Identification of the
coronary surface vasculature can also be performed indirectly with
dye injection into the vasculature during spiral CT scan or
fluoroscopy.
The cinching implants applied to the epicardial surface may have a
similar size tissue anchor and tether as the various transvascular
embodiments described herein, but in other embodiments, one or more
implants may have a longer tether and a greater number of anchors
to compensate for the greater diameter of the epicardial surface.
In some embodiments, the implants 724 may have anchors 726 with
wider eyelets 728 that are configured for slidable coupling to a
band-like tether 730, as depicted in FIG. 21B, which may permit the
use of fewer tissue anchors 726 and allows the band-type tether 730
to contact and restrain portions of the epicardium 732.
In addition to the use of the cinching implants to restrain
ventricular dilation and improve a patient's hemodynamic profile,
the cinching implants may also be used to splint dyskinetic wall
segments to the intact myocardium. In some instances, splinting of
dyskinetic wall segments may reduce paradoxical wall motion during
systole. The splinting of dyskinetic wall segments may also improve
forward flow through the ventricle and increase the ejection
fraction of the left ventricle, and/or valve function when one or
more papillary muscles are adjacent to a dyskinetic wall segment.
Referring to FIG. 19A, for example, the papillary muscle 708 of the
postero-lateral mitral valve leaflet MVL may be proximate to a
dyskinetic lateral wall segment 736 that causes leaflet
insufficiency during ventricular systole. By positioning a cinching
implant 734 across portions of the dyskinetic wall segment 736 and
the surrounding intact myocardium 738, the splinted dyskinetic wall
segment 736 may resist outward bulging forces during ventricular
systole and increase net forward blood flow. The cinching implants
734 used for splinting wall segments may rely on the tension of the
tether for splinting effect, but in some embodiments of the
invention, a rigid or semi-rigid tether or backbone may be used.
Also, in the particular embodiment depicted in FIGS. 19A and 19B,
the cinching implant is secured to the myocardium in a longitudinal
orientation, but one of skill in the art can image the heart
chamber and wall segments to determine the desired implant
orientation.
In the embodiments of the cinching implant described above, the
implants are configured for generally planar implantation along an
arcuate target tissue such as the ventricular wall or subannular
groove region. In other embodiments of the invention, the cinching
implants may have more complex configurations. FIGS. 22A to 22C,
for example, depict the implantation of a helical ventriculoplasty
implant 740. The longitudinal length of the helical implant 740 may
permit redistribution of the restraining force across a greater
number of tissue anchors 742. In some embodiments, the helical
anchor 740 may have a length of about 5 cm or more, preferably
about 7 cm or more, and most preferably about 9 cm or more. The
helical implant 740 may also be designed with a right-handed or
left-handed twist configuration, which may complement the
theoretical twisting orientation of the myocardial fibers
comprising the left ventricle LV.
To implant a ventricular device in a beating heart contracting
walls, in some embodiments one end of the implant may first
attached to a less mobile portion of the ventricle chamber. In FIG.
22A, the distal end 744 of the implant 740 is first secured to the
apical region 704 of the left ventricle LV. Once the distal end 744
of the implant 740 is stabilized, the delivery catheter 746 can be
stabilized using the secured distal end 744 and provides sufficient
stability to the delivery catheter 746 to assume the desired
geometric configuration and orientation. This can occur with a
delivery catheter 746 that is made from a shape memory material
with an helical geometry that can be reversibly straightened with a
movable stiffening wire or element (not shown) within the delivery
catheter 746. When the stiffening element is removed and the
delivery catheter 746 assumes the helical configuration as shown in
FIG. 22B, surface contact between the delivery catheter 746 and the
heart wall 651 can be maintained with distally directed force on
the delivery catheter 746. Manipulation of the distally directed
force can also be used to control the longitudinal length of the
heart chamber over which the helical implant 740 is positioned.
FIG. 22C depicts the implant 740 after withdrawal of the delivery
catheter 746.
In some alternate embodiments, the delivery catheter may be
pre-positioned along one or more portions of the subannular groove
region or the subvalvular space before the distal tissue anchor is
secured to the apex. In still other alternative embodiments, a
detachable tissue anchor or engaging structure may be provided
about the distal end of the guide wire, guide catheter or delivery
catheter to temporarily stabilize delivery catheter for
implantation of the cinching implant. After the implant is secured
to the myocardium, the detachable tissue anchor or engaging
structure may be disengaged from the myocardium and withdrawn from
the patient with the other components of the delivery system.
Referring now to FIGS. 23A and 23B, although the embodiments
described herein may utilize a cinching implant with a linear or
serial configuration, other embodiments may utilize a branched
cinching implant 748 having one or more branch sections 750 where
two or more arms 752, 754 of the implant 748 are joined. The
branched implant 748 may comprise a single tether or multiple
tethers 756, 758. Multiple tethers 756, 758 may permit the
individual arms 752, 754 of the implant 748 to be cinched to
different degrees. One example of a branched implant 748 implanted
in a ventricle is shown in FIG. 23B. This particular implantation
location may permit the reconfiguration of each papillary muscle to
occur with different amount of tension. Alternatively, of course,
two or more serially-configured cinching implants may also be
used.
With respect to the delivery of a branched cinching implant, the
delivery catheter 764 may be configured with separate openings for
each tissue anchor of the implant, as shown in FIG. 23C, wherein
the openings 766 for anchors on different arms of the implant are
circumferentially separated on the delivery catheter. In some
embodiments, the circumferentially separated openings may reduce
the risk that a branch tether may get tangled during delivery. In
other embodiments, however, all the tissue anchors are delivered
along a series of longitudinally spaced openings 770 on the
delivery catheter 768, as in FIG. 23D, or through a single opening
on the delivery catheter. Referring to FIG. 23A, the implant 748,
when loaded into the delivery catheter, may have one or more tether
sections 768 without any anchors and may require a substantial
amount of cinching to take of the additional slack on the
tether.
While this invention has been particularly shown and described with
references to embodiments thereof, it will be understood by those
skilled in the art that various changes in form and details may be
made therein without departing from the scope of the invention. For
all of the embodiments described above, the steps of the methods
need not be performed sequentially.
* * * * *